The present invention relates generally to an integrated pharmacy system having hardware and software components that totally or partially automate the medical prescription fulfillment process from entry of the prescription to payment and, more particularly, a method for automatically generating dispensing information for a selected medical item.
Integrated pharmacy systems are used to streamline the prescription fulfillment process. An exemplary integrated pharmacy system is disclosed in U.S. Pat. No. 5,597,995 to Williams entitled “Automated Medical Prescription Fulfillment System Having Workstations For Imaging, Filling, And Checking The Dispensed Drug Product,” issued 28 Jan. 1997 and incorporated by reference herein in its entirety.
The Williams patent discloses a pharmacy system for automating the medical prescription fulfillment process for a customer. It includes an imaging workstation having a host computer for receiving data entry of an original medical prescription for a prescribed drug product and customer information and for producing a prescription transaction data record, and an electronic communication device for communicating the prescription transaction data record from the host computer to a series of computers. A filling workstation includes dispensing apparatus for counting, dispensing, and packaging of the dispensed drug product into the drug vial for the customer. A checking workstation includes a scanner for scanning the bar code label on the drug vial, and a display for displaying the digitized image of the original medical prescription, and for displaying a digitized image of the prescribed drug product to allow a first visual comparison between the digitized image of the prescribed drug product and the dispensed drug product in the drug vial, and a second visual comparison between the digitized image of the original medical prescription and the dispensed drug product in the drug vial before it is given to the customer.
A common drug identifier used by integrated pharmacy systems is a National Drug Code (NDC). An NDC number is issued for each drug in the United States. The NDC is a 10-digit number typically containing three (3) segments or fields: the manufacturer or distributor code field, the product code field, and the package code field. The manufacturer or distributor code is assigned by the Food and Drug Administration (FDA), whereas the product and package codes are assigned by manufacturers or distributors.
The manufacturer or distributor code identifies the entity that manufactured or distributed the drug. The product code represents the drug name and strength. The package code represents the quantity (count, weight, mass or volume) in the stock container as delivered from the manufacturer or distributor. The three field representation may result in numerous NDC numbers being assigned to the same drug. Although numerous NDC numbers assigned to the same drug may be inefficient for drug identification, the NDC numbering scheme facilitates inventory management processes.
The NDC number may be represented in one of three different formats typically denoted as 4-4-2, 5-3-2 and 5-4-1. The first of the three segments represents the manufacturer or distributor code and may be either 4 or 5 digits. When the manufacturer code is 4 digits, the product code field will be 4 digits and the package code field will be 2 digits (i.e., the 4-4-2 format). When the manufacturer code is 5 digits, the manufacturer/distributor has an option of assigning either a 3 or 4 digit product code field followed by a 2 or 1 digit package code field (i.e., the 5-3-2 and 5-4-1 formats, respectively).
The NDC number is typically encoded on the stock container as a bar code using a UPC-A bar code symbology with a data format reserved for NDC numbers as defined by the Uniform Code Counsel (UCC). However, there are exceptions to the use of the UPC-A bar code symbology caused by manufacturer preferences, the dispensing of non-prescription products (i.e., over the counter (OTC) drug products), and delivery of non-pharmaceutical products (i.e., syringes, bandages and other supplies).
In addition to the NDC system used in the United States, foreign countries may use different drug identifiers. For example, Canada uses a Drug Identification Number (DIN) to identify drugs. The DIN is intended to represent a specific drug regardless of the manufacturer or distributor, however, it has been noted that manufacturers have unique DINs assigned to equivalent drugs (same drug name, strength, and therapeutic equivalence).
A Canadian drug package identifier uniquely identifies the quantity or amount of product within the stock container. A typical Canadian stock container uses the UPC-A bar code symbology and data formatting standards as defined by the UCC, however, there is no correlation between the UPC data value, DIN number, and package identifier. Because the UPC data value conforms to the UCC standard, the first 5-digits of the 10-digit UPC data value represents the manufacturer or distributor (as assigned by the UCC). The last 5-digits of the 10-digit UPC data value are assigned by the manufacturer or distributor as a product identifier. The 5-digit product identifier value creates a unique bar code value for each Canadian manufacturer and distributor for every drug and stock container quantity.
In addition to the NDC and DIN identifiers, other identification systems may be assigned (for example, by a manufacturer, supplier, pharmacy, etc.) to identify a medical item. For example, a general product index number (GPI), a general product code (GPC), and/or an internal reference code (IEN) may be assigned to a medical item by a manufacturer.
During a prescription filling transaction, it is common for a substitute drug to be dispensed in place of the specific drug that was requested (i.e., prescribed) by a treating physician. Drug substitution increasingly challenges US pharmacies trying to meet the reporting requirements related to a prescription filling transaction. The reporting requirements are typically established by third-party payors (e.g., an insurance company, Medicare, Medicaid, etc.). Third-party payors increasingly require more specific information on the actual drug dispensed to fill a prescription. Where in the past it may have been sufficient to report the drug and drug number as written by the physician, today the third-party payors may require that the exact drug name, drug number (e.g., NDC, DIN, GPI, etc.), and drug package size as dispensed be reported. In the future, it is anticipated that the third-party payors will require additional information on the actual drug dispensed. This may include the manufacturer's lot number or batch number to identify production specifics and the drug's expiration date from the manufacturer, distributor, labeler, or re-packager.
With prior art integrated pharmacy systems, the host computer's selection of a substitute drug to fill a prescription creates several problems. In a typical dispensing transaction, information (for example, from a physician, provider, pharmacy, customer, etc.) that is entered into the integrated pharmacy system is transmitted to a third-party clearinghouse for adjudication before the integrated pharmacy system activates a dispensing device. Adjudication refers to processing information entered into the integrated pharmacy system to determine whether a drug is approved by a third-party payor (i.e., determining if an insurance carrier will pay for, or reimburse a customer for, a given drug under a given insurance plan).
A problem inherent to prior art integrated pharmacy systems is that a new prescription label is not printed when a substitute drug is dispensed (i.e., the information related to the requested drug, not the substitute drug, is printed on the label). Although the requested and substitute drugs (or products) may be equivalent, they may be manufactured or distributed by different companies. Likewise, each drug may be identified by a unique manufacturer or distributor drug number or stock container indicia. Thus, substitution requires reliance on the pharmacy technician to dispense the proper substitute drug using a label that corresponds to the requested drug, not the drug selected for substitution. Additionally, substitution creates inventory and reporting problems which complicate the pharmacy's auditing procedures.
The multiple identification numbers for substitute drugs within a single identification system (e.g., multiple NDC numbers for the same drug), the multiple identification systems (e.g., the NDC system, the DIN system, etc.), and the increased reporting specificity required by third-party payors create burdens on pharmacy technicians and pharmacists tasked with filling a prescription. Ideally during the prescription fulfillment process, the pharmacy technician and pharmacist are focused on filling each prescription with the correct drug (i.e., name and strength). In reality, however, the pharmacy technician and pharmacist are distracted from this role by the multiple identification numbers for substitute drugs and the requirements established by third-party payors.
Thus, there exists a need for an integrated pharmacy system having hardware and software components that automate the medical prescription fulfillment process from entry of the prescription to payment. More specifically, there exists a need for a method of automatically generating dispensing information that may be used to manually or automatically fill a prescription with a requested drug or an appropriate substitute drug.